Severity 4 of 5
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
The Compounding Pharmacy of America is recalling L-Arginine 100 mg/ml Injectable due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Morphine and Bupivacaine Solution due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
The Compounding Pharmacy of America is recalling HCG 625 IU/ml Injection kits due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix AT-1 Injectable due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Tri-Mix Injectable due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Progesterone 100 mg/ml Injection due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling Fentanyl and Bupivacaine Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone Cypionate and Anastrazole Injection because FDA inspections found GMP violations that may affect sterility.
Yamaha is recalling 2015 YZF-R3 motorcycles because the upper triple clamp may crack, potentially causing loss of steering control and increasing crash risk.
The Compounding Pharmacy of America is recalling HCG 1,000 IU/ml Injection kits nationwide due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Cyanocobalamin and B-Complex injections due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Magnesium Chloride 200 mg/ml Injection due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
The Compounding Pharmacy of America is recalling Morphine and Bupivacaine solution because FDA inspections found violations that may affect sterility.
Lumenis is recalling VersaCut+ Tissue Morcellator hand pieces because they may operate unpredictably during surgery, potentially damaging non-target tissue.
The Compounding Pharmacy of America is recalling Alprostadil 50 mcg/ml Injection because an FDA inspection found GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Hydromorphone 10 mg/ml Intrathecal Solution because FDA inspections found GMP violations that may affect sterility.
The Compounding Pharmacy of America is recalling Tri-Mix ST4 Injectable due to GMP violations that may impact sterility. The recall covers lots distributed nationwide from November 2014 to May 2015.
The Compounding Pharmacy of America is recalling Tri-Mix MEDIUM Injectable nationwide due to FDA inspection findings of GMP violations that impact sterility.
The Compounding Pharmacy of America is recalling HCG and Methylcobalamin injections due to FDA inspection findings of GMP violations that may impact sterility.
Tipico Products Company is recalling 2,000 pounds of Dry Grated Romano in Iowa due to a health risk from Listeria monocytogenes.
Daimler Trucks North America is recalling 2014-2016 Freightliner trucks because rear brake calipers may contact the spring suspension, reducing braking performance.
KYMCO is recalling 2015 Super 8-50 X and Super 8-150 X scooters because the front brake hose may contact the tire, risking brake failure and crashes.
Crossroads is recalling 2015-2016 Sunset Trail trailers because kitchen ranges lack an isolation panel, creating a risk of fire, explosion, or carbon monoxide buildup.
Suzuki is recalling 2012-2013 SX4 vehicles because the power steering pump may seize, causing loss of steering assist and increasing crash risk.
Eaton is recalling specific FR-Series 10-speed manual transmissions because the reverse gear may stay engaged, causing the vehicle to move backwards unexpectedly.